Department: Engineering & Maintenance | Industry: API / Bulk Drugs / Pharmaceutical Manufacturing

- Job Purpose To lead the Engineering and Maintenance function for API manufacturing facilities, ensuring maximum equipment reliability, uninterrupted plant operations, regulatory compliance, cost optimization and effective management of engineering infrastructure, utilities, projects and maintenance activities.

The role will be responsible for driving engineering excellence across manufacturing blocks, utilities, process equipment and infrastructure while ensuring compliance with cGMP, EHS, regulatory requirements and applicable engineering standards.
- Key Responsibilities

A. Engineering & Maintenance Management
- Lead the overall Engineering and Maintenance function for API manufacturing facilities.
- Develop and implement preventive, predictive and breakdown maintenance strategies to maximize equipment uptime.
- Ensure reliability and availability of critical process equipment, including reactors, centrifuges, ANFDs, filter dryers, heat exchangers, pumps, agitators, scrubbers and vacuum systems.
- Establish maintenance schedules, equipment criticality assessments and annual maintenance plans.
- Monitor equipment breakdowns, mean time between failures (MTBF), mean time to repair (MTTR) and maintenance costs.
- Drive root cause analysis (RCA) and corrective/preventive actions for recurring equipment failures.
- Ensure timely availability of engineering spares, tools, consumables and critical maintenance materials.
- Implement equipment lifecycle management, asset integrity and reliability improvement initiatives.

B. Utilities & Infrastructure Management
- Manage plant utilities, including:
- Boilers, steam and condensate systems
- Cooling towers and chilled water systems
- HVAC and ventilation systems
- Compressed air and nitrogen systems
- Vacuum systems
- Water treatment, DM water and other process-water systems
- Effluent treatment and associated utility infrastructure
- Electrical distribution systems, DG sets and transformers, in coordination with the Electrical team
- Ensure reliable utility supply to manufacturing operations.
- Monitor utility consumption and implement energy and water conservation initiatives.
- Ensure statutory inspections, certifications and preventive maintenance of applicable utility equipment.

C. API Process Equipment & Plant Reliability
- Ensure safe and reliable operation of engineering systems supporting API and intermediate manufacturing.
- Oversee maintenance and integrity of reactors, pressure vessels, agitators, centrifuges, filter dryers, solvent recovery systems and process piping.
- Ensure appropriate material selection, corrosion control and maintenance practices for SS, alloy and other process-contact equipment.
- Coordinate with Production, QA, QC, EHS and Process Engineering teams for equipment-related issues.
- Ensure maintenance activities do not compromise product quality, process safety or contamination-control requirements.
- Support equipment modifications and process improvements in accordance with approved change-control procedures.

D. Capital Projects & Engineering Projects
- Lead engineering projects related to plant expansion, capacity enhancement, equipment installation and infrastructure upgrades.
- Prepare annual capital expenditure (CAPEX) proposals,



technical specifications and project budgets.
- Manage engineering design reviews, vendor selection, equipment procurement, installation and commissioning.
- Ensure project execution within approved budgets, timelines and quality standards.
- Coordinate qualification, commissioning and handover of new equipment and systems in collaboration with QA, Validation, Production and EHS.
- Ensure proper engineering documentation, as-built drawings and maintenance manuals.

E. Regulatory Compliance & cGMP
- Ensure engineering systems and maintenance practices comply with applicable cGMP requirements and relevant regulatory expectations.
- Maintain engineering documentation, including preventive maintenance records, breakdown reports, calibration coordination, equipment history and qualification records.
- Support regulatory inspections and customer audits by ensuring engineering documentation and facilities are inspection-ready.
- Ensure effective implementation of change control, deviation investigations and CAPA related to engineering activities.
- Coordinate with QA and Validation teams for equipment qualification, utility qualification and periodic review requirements, as applicable.
- Ensure compliance with applicable statutory requirements for pressure vessels, boilers, lifting equipment, electrical installations and other regulated systems.

F. EHS & Process Safety
- Ensure engineering work complies with plant safety procedures and applicable statutory requirements.
- Drive safe maintenance practices, including Permit-to-Work, Lockout/Tagout (LOTO), hot work, confined-space entry and work-at-height controls.
- Support process safety initiatives, including equipment integrity, corrosion monitoring and safe management of hazardous process systems.
- Ensure appropriate maintenance and testing of safety-related engineering systems.
- Investigate engineering-related incidents, identify root causes and implement corrective actions.
- Promote a proactive safety culture across engineering employees and contractors.

G. Budgeting & Cost Optimization
- Prepare and manage the annual engineering operating budget and CAPEX plan.
- Optimize maintenance expenditure, spare-parts inventory and contractor costs without compromising safety or compliance.
- Implement energy-saving initiatives and improve utility efficiency.
- Drive equipment standardization, lifecycle cost reduction and reliability improvement projects.
- Review engineering performance against approved budgets and operating KPIs.

H. Team Leadership & Development
- Lead and develop engineering teams across mechanical maintenance, utilities, projects and associated technical functions.
- Establish clear responsibilities, performance targets and competency development plans.
- Ensure adequate technical manpower, shift coverage and emergency breakdown response.
- Develop SOPs, maintenance standards and technical training programs.




- Manage engineering contractors and service providers, ensuring quality, safety and timely execution.
- Foster cross-functional collaboration with Production, QA, EHS, Procurement, Projects and HR.

3. Qualification
- B.E./B.Tech in Mechanical Engineering preferred.
- B.E./B.Tech in Electrical or Chemical Engineering may be considered for candidates with substantial engineering leadership experience in API manufacturing.
- M.E./M.Tech or a management qualification will be an advantage.

4. Experience
- 15–20 years of overall experience in Engineering and Maintenance.
- At least 5–8 years in a senior engineering leadership role, such as Head Engineering, GM Engineering, DGM Engineering or AGM Engineering.
- Significant experience in API, bulk drugs, intermediates or specialty chemical manufacturing.
- Proven experience in handling large-scale manufacturing facilities, critical process equipment, utilities, maintenance operations and engineering projects.
- Experience in regulatory inspections, cGMP compliance, equipment qualification and EHS management is preferred.

5. Essential Technical Competencies
- API process equipment and maintenance engineering
- Mechanical integrity and reliability engineering
- Preventive and predictive maintenance
- Utility systems and energy management
- Process piping, pressure vessels and corrosion management
- Capital projects and commissioning
- cGMP documentation and change control
- RCA, FMEA, MTBF and MTTR
- CAPEX/OPEX budgeting
- EHS and process safety
- Contractor and manpower management

6. Key Performance Indicators (KPIs)

KPI

Measurement

Equipment availability

Achievement against approved plant targets

Breakdown maintenance

Reduction in unplanned downtime

Preventive maintenance

100% completion as per approved schedule, subject to authorized rescheduling

Utility reliability

Uninterrupted supply to manufacturing operations

Maintenance cost

Performance against approved annual budget

Energy efficiency

Reduction in specific energy and utility consumption

Regulatory compliance

Timely closure of engineering observations and CAPAs

Project execution

Completion within approved cost and timeline

EHS performance

Reduction in engineering-related incidents and unsafe acts

Team effectiveness

Skill development, productivity and manpower utilization
- Key Stakeholder Interfaces

- Site Head / Plant Head
- Head – API Manufacturing / Production
- Quality Assurance and Quality Control
- EHS / Process Safety
- Projects and Validation
- Procurement and Supply Chain
- Finance
- Corporate Engineering and senior management

8. Ideal Candidate Profile The ideal candidate should be a seasoned engineering leader with strong hands-on understanding of API manufacturing equipment, mechanical maintenance, utility infrastructure, plant reliability and regulatory compliance. The candidate must have demonstrated the ability to lead multidisciplinary teams, manage engineering budgets, execute expansion projects and improve equipment uptime in a complex chemical or pharmaceutical manufacturing workplace. Preferred candidate: An Engineering Head from an API or bulk-drug manufacturing company who has managed reactors, centrifuges, filter dryers, pressure vessels, solvent recovery systems, critical utilities and large-scale maintenance operations.

📌 GM:- API Engineering (Ankleshwar)
🏢 Cadila Pharmaceuticals
📍 Ankleshwar